FDA WARNING_LETTER - Wagner Dairy Operations LLC - February 07, 2014

On February 5 and 7, 2014, the FDA investigated Wagner Dairy Operations, LLC, identifying violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved selling an adulterated dairy cow for slaughter on October 7, 2013. USDA/FSIS analysis of tissue samples from this animal, slaughtered on October 8, 2013, revealed desfuroylceftiofur (ceftiofur marker residue) at 1.43 ppm in kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 CFR 556.113(b)(3)). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the investigation found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. Specifically, the firm failed to maintain treatment records for medicated animals and lacked an adequate system to ensure withdrawal times were observed before slaughter. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Wagner Dairy Operations, LLC is required to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective steps, including documentation, must be submitted to the FDA within 15 working days of receiving the letter. Failure to comply may result in